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Teva Quality Analyst India, Maharashtra, Navi Mumbai 479475261
22.12.2024
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How you’ll spend your day
- Audit each BA/BE studies (both pre and post study) to assure the management that the facilities, personnel, equipment, instruments, protocols, methods, practice, records and controls are in conformance with the relevant and current GCP / applicable GLP guidelines, protocols and SOPs.
- Review the SOPs, forms, formats and logbooks of all the department(s) and give comments on the same.
- To review the change control and deviations as and when assigned.
- Prepare audit report to adhere with the guidelines, written procedures and regulatory inspections and ensure compliance from user department to audit reports.
- To review method SOP’s as and when assigned.
- Conduct in-process study audit in order to ensure the compliance to GCP/GLP, Protocols, SOPs and applicable regulatory requirements.
- Audit of generated raw data and respective validation report, addendum, bioanalytical report generated from method validation, partial method validation, subject sample analysis of clinical study.
- To share QA audited concentration data to Biostatistician as per business timelines.
- To audit of PK and statistical output of clinical study as per the requirement.
- To audit Bio-summary tables (OGD), eCTD compilation of clinical studies.
- Review overall study through audit of ongoing studies, reports and documentation and release the study specific audit certificate.
- To co-ordinate with user department and medical writer for finalization of bioanalytical reports and clinical study reports.
- Review of audit trail on LC-MS/MS instrument.
- To conduct area specific audit, system audits and vendor audits as and when assigned.
- To audit calibration records/ qualification records of instruments/equipment’s for bioanalytical as and when assigned.
- Control and issue the documents i.e. SOPs, forms, formats, logbooks, study specific protocols, validation protocols, and qualification protocols of all departments of WPPL.
Your experience and qualifications
- B.Pharm, M.Pharm OR M.Sc
- 3-6 Years of experience into Bioanalytical Quality Assurance for a BABE Study
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